CClinicalTrials.gg
CompletedNCT02771652ms-intaktUpdated Jun 24, 2016

Effect of an Internet-based At-home Physical Training Protocol on Quality of Life, Fatigue, Functional Performance, Aerobic Capacity and Muscle Strength in Multiple Sclerosis Patients

An interventional study of e-training and Control in Multiple Sclerosis, sponsored by University of Erlangen-Nürnberg. Completed. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-06-24.

Sponsored by University of Erlangen-Nürnberg · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
126
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
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Study summary

In this randomised controlled trial, the feasibility and effectiveness of an internet-based exercise intervention including progressive strength and endurance training (e-training) for PwMS was investigated. Primary outcome was health-related quality of life, secondary outcomes were muscle strength, aerobic capacity and lung function, physical activity and fatigue.

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Conditions studied

  • Multiple Sclerosis

Keywords

  • Multiple Sclerosis
  • Quality of Life
  • exercise
  • internet
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In context

Multiple Sclerosis

3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.

This study's enrollment of 126 is above the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

University of Erlangen-Nürnberg is the lead sponsor of 21 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • diagnosed Multiple Sclerosis (McDonald criteria),
  • an EDSS score of less than or equal to 4.0,
  • not less than 4 weeks of clinical stability prior to inclusion in the study,
  • access to the internet.
  • the taking of immunotherapeutic agents was not relevant and not monitored

Exclusion criteria

Exclusion Criteria:

  • primary progressive multiple sclerosis
  • clinically relevant internal disease, especially cardiovascular or pulmonary disease, metabolic and orthopedic diseases
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
126 participants (actual)

Study arms

  • Active comparator
    e-training intervention

    Resistance and endurance training

    Behavioral: e-training

  • Other
    Control

    no exercise

    Other: Control

Interventions

  • Behaviorale-training

    The e-training intervention is a home-based aerobic and resistance training program. Resistance training was prescribed twice weekly for a period of 12 weeks. No special equipment was necessary except an elastic exercise band or a large gymnastic ball. In addition, endurance training was to be carried out once a week. Training intensity was regulated by the participant's subjective, perceived exertion, which was rated between 6 and 20 on the BORG Scale. The form of activity for the endurance training was freely selected, duration (between 10-60 min) was adjusted to individual fitness levels. Therapists aimed at eliciting a BORG Feedback of between 11 (fairly light) and 16 (hard). The exercise training was home-based and supervised via the internet. Participants continued exercise training for another 12 weeks after the 3month assessment.

  • OtherControl

    After the initial assessment on entry, those assigned to the control group were instructed to maintain their previous physical activity behaviour. After waiting three months, they received the same e-training intervention as the intervention group had received from the start.

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What researchers measure

Primary outcomes

  1. Change in Hamburg Quality of Life Questionnaire for Multiple Sclerosis (HAQUAMS)

    38 items generate the subscales of fatigue/thinking, mobility of the lower/upper extremities, communication and mood. The HAQUAMS total score is calculated from a mean of the subscales, providing a total score between 1 and 5. Higher scores in HAQUAMS indicate lower levels in HRQoL. The primary outcome will be the change over time from baseline to month 3.

    Time frame: Assessments took place at baseline and at 3 months

Secondary outcomes

  1. Würzburg Fatigue Scale (WEIMuS)

    This questionnaire contains 17 items that form a physical and cognitive subscale. The total score ranges from zero to a maximum of 68 points (maximum fatigue). The cut-off value for the presence of fatigue is above 32.

    Time frame: Assessments took place at baseline, at 3 and 6 months

  2. Muscle strength lower extremities

    Maximum isometric muscle strength was tested with the M3 Diagnos machine (Schnell, Peutenhausen, Germany).

    Time frame: Assessments took place at baseline and after 3 and 6 months

  3. Forced vital capacity

    Forced vital capacity (FVC) was tested with the Master Screen CPX System (Viasys Healthcare, Cardinal Health, Germany).

    Time frame: Assessments took place at baseline and after 3 and 6 months

  4. Aerobic capacity

    As a marker of endurance capacity, maximal oxygen uptake (VO2peak) was determined by the spiroergometry device Master Screen CPX on a bicycle ergometer (Sanabike 250F, MESA, Germany) at 70-80 revolutions per minute.

    Time frame: Assessments took place at baseline and after 3 and 6 months

  5. Physical activity

    Habitual physical activity was assessed with the German version of the Baecke Questionnaire including three activity indices (work, sport, leisure time PA). There were limitations concerning content validity in all indices; therefore, the sport score of the sport index was used. That score is the product of the intensity, duration and frequency of a participant's reported sports activities. Higher scores indicate a higher level of PA.

    Time frame: Assessments took place at baseline and after 3 and 6 months

  6. Peak expiratory flow

    Peak expiratory flow (PEF) was tested with the Master Screen CPX System (Viasys Healthcare, Cardinal Health, Germany).

    Time frame: Assessments took place at baseline and after 3 and 6 months

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Tallner A, Tzschoppe R,Peters S, Mäurer M, Pfeifer K. Internetgestützte Bewegungsförderung bei Personen mit Multipler Sklerose. Neurologie und Rehabilitation 19(1): 35-46, 2013.

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02771652
Lead sponsor
University of Erlangen-Nürnberg
Collaborators
Caritas-Krankenhaus Bad Mergentheim
Responsible party
Prof. Dr. Klaus Pfeifer (Prof. Dr., Friedrich-Alexander-Universität Erlangen-Nürnberg) — Principal investigator
First posted
May 13, 2016
Start date
Feb 2010
Primary completion
Jun 2011
Completion
Nov 2011
Last update
Jun 24, 2016

Study contacts

Matthias Mäurer, Dr.
principal investigator · Caritas-Krankenhaus Bad Mergentheim

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.

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